A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma (Intrim 1 study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Jan 2020 → ongoing

Decision date (initial)

2024-12-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509461-20-00

EudraCT number

2018-001992-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To investigate if local administration of IMO-2125 results in lower rates of tumor positive SLN in patients with pT3-4 cN0M0 melanoma.

Secondary objectives 2

1. to investigate if locally administered IMO-2125 is capable of increasing the frequency and activation state of lymph node-resident conventional dendritic cell (DC) subsets and melanoma antigen-specific T cells in the SLN and peripheral blood in patients with pT3-4 cN0M0 melanoma
2. to compare RFS and OS at 18 months, 24 months, 36 months, 5 years and 10 years after the SNB of patients with pT3-4 cN0M0 melanoma who received either 8 mg IMO-2125 or placebo.

Conditions and MedDRA coding

pT3-4 cN0M0 Melanoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients must be willing and able to sign the informed consent and comply with the study protocol.
2. Must be ≥18 years of age.
3. WHO Performance Status ≤1.
4. Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
5. Women of childbearing potential (WOCBP) and fertile men must agree to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration.

Exclusion criteria 7

1. Known hypersensitivity to any oligodeoxynucleotide.
2. Active autoimmune disease requiring disease-modifying therapy at the time of screening.
3. Pathologically confirmed loco-regional or distant metastasis.
4. Non-skin melanoma
5. Patients with another primary malignancy that has not been in remission for at least 3 years with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
6. Active systemic infections requiring antibiotics.
7. Women who are pregnant or breast-feeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The rate of tumor positive SLN seven days after the experimental treatment.

Secondary endpoints 3

1. Frequency and activation state of lymph node resident (LNR) conventional dendritic cells (DC) and melanoma antigen-specific T cell responses in the SLN and peripheral blood.
2. RFS at 18 months, 24 months, 36 months, 5 years and 10 years after SNB.
3. OS at 18 months, 24 months, 36 months, 5 5 years and 10 years after SNB.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

F. van den Eertwegh

Public contact point

Organisation

Amsterdam UMC

Contact name

F. van den Eertwegh

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications